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United Kingdom, Warrington 80.00 GBP / Hour · Job Posted April 16, 2026
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Job Description
Are you a proactive regulatory professional looking to lead critical compliance activities in the life sciences sector? We are seeking a Sr. Regulatory Affairs Specialist to join a dynamic international team for a 12-month contract. This role offers the flexibility of remote or hybrid working and is based out of Warrington.
Job Responsibility
Lead and manage notification activities for IVDR CDx performance studies involving leftover samples
Prepare, review, and submit notification packages to EU Competent Authorities and Ethics Committees
Partner with Clinical, Medical, Legal, Quality, and Project Management teams to ensure submissions are both compliant and timely
Act as the primary point of contact for EU regulatory authorities, responding to inquiries and requests for additional information
Provide regulatory expertise to project teams regarding study design and documentation requirements
Requirements
Bachelor's degree in Life Sciences, Biomedical Sciences, or a related field
At least 3+ years in Regulatory Affairs or Clinical Regulatory functions within the IVD, medical device, or pharmaceutical industry
Solid working knowledge of IVDR (EU2017/746), particularly regarding performance studies
Proven experience with EU regulatory submissions and interactions with Competent Authorities
Strong project management abilities
Excellent English communication skills
Ability to work autonomously in a matrixed environment